ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM
Received Sep 10, 2025 · Event occurred Mar 29, 2025
Report 3006425876-2025-00853 · MDR key 23016558
Device
Generic name
Catheter Hemodialytsis Non Imp
Manufacturer
Arrow International LlcCatalog number
CS-25142-F
Lot number
UNKNOWN
Product problems
- Device Slipped
- Detachment of Device or Device Component
- Migration
- Device Slipped
- Detachment of Device or Device Component
- Migration
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT " WE HAVE NOW HAD 4 OF THESE LINES BECOME DISLODGED DURING ROUTINE NURSING CARE OF CRITICALLY ILL PATIENTS. WHILST A SMALL AMOUNT OF TENSION WILL INEVITABLY BE APPLIED TO THESE LINES, WE HAVE NO EVIDENCE THAT UNDUE FORCE WAS APPLIED. THIS HAS HAPPENED WITH DIFFERENT MEMBERS OF STAFF, IN DIFFERENT PATIENTS, OVER SEVERAL MONTH PERIOD." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00853, 3006425876-2025-00854, 3006425876-2025-00855, AND 3006425876-2025-00856.
Additional Manufacturer Narrative
(B)(4). ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER CLARIFYING THAT THERE WAS ONLY ONE EVENT INVOLVING ONE PATIENT; THEREFORE, THE INITIAL MDR 3006425876-2025-00853, SUBMITTED ON 10-SEP-2025, SHOULD BE RETRACTED.
Description of Event or Problem
IT WAS REPORTED THAT " WE HAVE NOW HAD 4 OF THESE LINES BECOME DISLODGED DURING ROUTINE NURSING CARE OF CRITICALLY ILL PATIENTS. WHILST A SMALL AMOUNT OF TENSION WILL INEVITABLY BE APPLIED TO THESE LINES, WE HAVE NO EVIDENCE THAT UNDUE FORCE WAS APPLIED. THIS HAS HAPPENED WITH DIFFERENT MEMBERS OF STAFF, IN DIFFERENT PATIENTS, OVER SEVERAL MONTH PERIOD." ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER; HOWEVER, FURTHER DETAILS HAVE NOT BEEN PROVIDED AT THIS TIME. ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00853, 3006425876-2025-00854, 3006425876-2025-00855, AND 3006425876-2025-00856.